BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1964358 · Received January 19, 2011

    Report

    Report Number
    2031642-2011-00024
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    November 17, 2010
    Report Date
    December 21, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): POWER SUPPLY.

    Description of Event or Problem · 1

    WHILE SERVICING THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN NOTED A DIAGNOSTIC CODE IN THE VENTILATOR'S LOG HISTORY INDICATING A 24/+-12V/POWER FAIL CONDITION. THE CUSTOMER DID NOT REPORT THE OCCURRENCE DURING ANY PREVIOUS USAGE AND THERE WAS NO PATIENT HARM REPORTED. THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE FINDING. THE POWER SUPPLY WAS REPLACED TO ADDRESS THE FINDING. IF A POWER FAILURE OF THE VENTILATOR OCCURS DURING USE, AN AUDIBLE ALARM WILL ACTIVATE. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1